CPhI Online

Managing Your Life Sciences Quality Management System Remotely

1 Sep 2020

Telecommuting and online commerce has been with us for some time and works seamlessly in many industries, but the current state of events has forced companies to apply remote management to other areas that have historically been considered "hands-on" job functions.

Working in a GMP environment has always been considered one of those "hands-on" industries, though some functions and areas can be approached remotely though automation and telecommuting. One of those GMP areas is Quality Assurance and the management of the quality systems.

The on-site presence of Quality Assurance and the use of paper documentation has historically been the norm for many GMP companies, with on-site audits and face-to-face meetings to discuss KPIs, investigations, corrective actions, and other quality systems interactions. While there will always be the need for an on-site presence for Quality Assurance, many of the modern-day tools can greatly reduce the numbers and hours of Quality Assurance staff required to be on-site.

Virtual Meetings SGS runs a network of integrated life science laboratories across North America, Europe and Asia-Pacific, which are all USFDA registered as Drug Establishments and strictly adhere to the GMPs according to 21 CFR 210 and 211. As an international network, the teams regularly use electronic means of communication, such as Skype and Microsoft Teams to conduct meetings and communicating at global and regional level. These virtual meetings have proven effective in bringing subject matter experts together and to effectively resolve issues remotely.

With the recent events of the COVID-19 pandemic and the need for physical distancing, local on-site meetings and training sessions now also use virtual technology effectively, with employees on-site attending safely from their desks, and in compliance with the GMP regulations.

Electronic QMS Tools Customer audits, GxP compliance, and regulatory inspections require that the Quality Assurance team to have strong oversight of the Quality Management System (QMS). Previously, use of paper-based systems records for investigations, deviations, OOS, Change Control, Audit observations and CAPA would have prevented the management of the QMS processes remotely.

A strong Quality Management System (QMS) has always been a high priority for SGS and in 2019, SGS' global life Science network embarked on the implementation of TrackWise Digital (TWD), an electronic tool which enabled Quality Managers and Supervisors to take a remote, yet in-depth approach to managing the QMS. This "out-of-the-box" TrackWise offering has the advantage of bringing all the benefits of the popular on-premise version into a fast-implementation and highly compliant digital cloud-based version.

With minimal configuration, SGS was able to leverage much of the system validation that was performed and documented by Sparta Systems, the developers of the TWD software. Being able to qualify and implement the TWD QMS system in this manner offered us the advantage to prepare our laboratories to effectively manage the quality systems remotely when the COVID-19 pandemic struck.

Quality Events for the management of deviations and OOS investigations make it simple to discuss root causes and plan corrective actions. Virtual internal and external audits are easy to maintain through review of electronic QMS data and scanned documents. The ability to run customized reports with filters to drill down to specific processes or key problem areas and allows for quick action as well as the implementation of more effective CAPA.

The use of bespoke dashboards provides a quick and effective way to get a remote snapshot of the QMS across the entire network, from any location across the world, and allows important GMP decisions to be made. Key stakeholders can collaborate by accessing the specific Quality Events from various laboratory sites, review trends and reports, and meet virtually to manage root cause and risks safely.

Onevision Digitalization Project

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